Commission Implementing Regulation (EU) 2023/2734 of 7 December 2023 concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, dairy ruminants and pigs (holder of authorisation: Mazzoleni S.p.A.)
Date: 2023-12-07
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: animal feedingstuffs, cattle, dairy production, equidae, food additive, market approval, swine








L_202302734EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2734


8.12.2023







            COMMISSION IMPLEMENTING REGULATION (EU) 2023/2734
of 7 December 2023
         
concerning the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, dairy ruminants and pigs (holder of authorisation: Mazzoleni S.p.A.)
(Text with EEA relevance)


THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,


Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (1), and in particular Article 9(2) thereof,

Whereas:







(1)


Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation.












(2)


In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.












(3)


The application concerns the authorisation of a preparation of Saccharomyces cerevisiae DBVPG 48 SF as a feed additive for horses, ruminants and all pigs, requesting that additive to be classified in the category ‘zootechnical additives’ and in the functional group ‘digestibility enhancers’ as regards horses, and in the functional group ‘other zootechnical additives’ as regards ruminants and pigs.












(4)


The European Food Safety Authority (‘the Authority’) concluded in its opinion of 23 March 2023 (2) that, under the proposed conditions of use, the preparation of Saccharomyces cerevisiae DBVPG 48 SF is safe for horses, ruminants and all pigs, consumers and the environment. It also concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF is not irritant to the eyes and skin but should be considered a respiratory sensitiser, while it could not conclude on the skin sensitisation potential of that preparation. The Authority further concluded that the preparation of Saccharomyces cerevisiae DBVPG 48 SF has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs, but was not in the position to conclude on the efficacy of that preparation for ruminants other than dairy ruminants. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.












(5)


The applicant committed on 13 June 2023 to submit supplementary information with a view to demonstrate the efficacy of the preparation of Saccharomyces cerevisiae DBVPG 48 SF for ruminants other than dairy ruminants.












(6)


In view of the above, the Commission considers that the preparation of Saccharomyces cerevisiae DBVPG 48 SF satisfies the conditions for authorisation provided for in Article 5 of Regulation (EC) No 1831/2003 for horses, dairy ruminants and all pigs. Accordingly, the use of that preparation should be authorised for horses, dairy ruminants and all pigs. In addition, the Commission considers that appropriate protective measures should be taken to prevent adverse effects on the health of the users of the additive.












(7)


The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,





HAS ADOPTED THIS REGULATION:



Article 1

Authorisation

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional groups ‘digestibility enhancers’ and ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.


Article 2

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.





This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 7 December 2023.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 268, 18.10.2003, p. 29.

(2)  
            EFSA Journal 2023;21(4):7971.




ANNEX














Identification number of the additive


Name of the holder of authorisation


Additive


Composition, chemical formula, description, analytical method


Species or category of animal


Maximum age


Minimum content


Maximum content


Other provisions


End of period of authorisation




CFU/kg of complete feedingstuff with a moisture content of 12 %





Category of zootechnical additives. Functional group: digestibility enhancers





4d24


Mazzoleni S.p.A.



Saccharomyces cerevisiae DBVPG 48 SF



Additive composition

Preparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:
1 × 109 CFU/g of additive.
Solid forms.

Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae DBVPG 48 SF.

Analytical method
 (1)







—


Identification: polymerase chain reaction (PCR) method – CEN/TS 15790










—


Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method (EN 15789)






Horses


-


3 × 109



-








1.


In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.










2.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.






28 December 2033





Category of zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)





4d24


Mazzoleni S.p.A.



Saccharomyces cerevisiae DBVPG 48 SF



Additive composition

Preparation of Saccharomyces cerevisiae DBVPG 48 SF with a minimum concentration of:
1 × 109 CFU/g of additive.
Solid forms.

Characterisation of the active substance

Viable cells of Saccharomyces cerevisiae DBVPG 48 SF.

Analytical method
 (1)







—


Identification: polymerase chain reaction (PCR) method – CEN/TS 15790










—


Enumeration in the feed additive, premixtures and compound feed: pour or spread plate method (EN 15789)






Dairy cows
All minor dairy ruminants


-


4 × 108



-








1.


In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.










2.


For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing and skin protective equipment.






28 December 2033




Pigs for fattening
Piglets (suckling and weaned)
Minor porcine species (suckling piglets, weaned piglets and pigs for fattening)


4 × 109





Sows for reproduction
Minor porcine species (sows for reproduction)


6 × 109







(1)  Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en



ELI: http://data.europa.eu/eli/reg_impl/2023/2734/oj
ISSN 1977-0677 (electronic edition)